Nine new medicines were recommended for marketing approval at the last meeting of the of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), bringing the total to 93 for 2015.
At the December meeting, the CHMP recommended a conditional marketing authorisation for AZ' targeted lung cancer therapy, Tagrisso (osimertinib), after a review under the EMA’s accelerated assessment programme.
Another medicine for lung cancer, Lilly’s Portrazza (necitumumab), also received a positive opinion from the Committee, as did Neofordex (dexamethasone), a medicine with an orphan designation for the treatment of symptomatic multiple myeloma. Neofordex was submitted as a hybrid application, which relies in part on the results of studies carried out with a reference product and in part on new data.
Also, CHMP recommended Shield’s Feraccru (ferric maltol) for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease, AstraZeneca‘s Zurampic (lesinurad) for hyperuricaemia, or an excess of uric acid in the blood, and Sanofi Pasteur’s Vaxelis, a vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B.
Bayer Pharma’s Iblias and Kovaltry (octocog alfa) received positive opinions for the treatment and prophylaxis of bleeding in patients with haemophilia A. These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisation applications of both medicines.
One generic medicine received a positive opinion from the Committee: Caspofungin Accord (caspofungin) for the treatment of fungal infections.